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[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102911-102912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29954]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4974]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Advanced 
Manufacturing Technologies Designation Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by January 17, 2025.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0139. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Advanced Manufacturing Technologies Designation Program

OMB Control Number 0910-0139--Revision

    This information collection supports the establishment of an FDA 
Advanced Manufacturing Technologies (AMT) Designation Program, as 
provided for in section 506L of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 356l). Intending to enhance the development 
of and combat the shortage of critical medical products, the AMT 
Designation Program encourages early adoption of new technological 
advances in manufacturing processes by the pharmaceutical industry or 
other drug/

[[Page 102912]]

biologic developers. FDA regulations in 21 CFR parts 210 and 211 govern 
current good manufacturing practice in the manufacturing, processing, 
packing, or holding of drugs and finished pharmaceuticals (including 
medical gases and active pharmaceutical ingredients), respectively. 
Applicable information collection and attendant burden are currently 
discussed, accounted for, and approved in OMB control number 0910-0139.
    We are revising the information collection to include the AMT 
Designation Program within the scope of activity, as authorized by 
section 506L of the FD&C Act, and account for attendant burden. 
Requests for AMT designation are reviewed by FDA to evaluate whether 
the data and information submitted meets the criteria established in 
section 506L of the FD&C Act. If a request for AMT designation is 
granted, then future new drug application (NDA), abbreviated new drug 
application (ANDA), or biologics license application (BLA) applicants 
may use or reference the designated AMT, noting specific application of 
the designated AMT to specific product development and inclusion in 
NDA, ANDA, or BLA submissions describing development and manufacturing 
processes. Also required by section 506L of the FD&C Act, we engaged 
with our stakeholders in a public meeting on June 8, 2023 (April 24, 
2023, 88 FR 24807), to discuss innovative manufacturing technologies 
for drug and biological products and included a discussion of the AMT 
Designation Program. For more information regarding AMT, we invite 
readers to visit our website at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/advanced-manufacturing, which 
includes regular updates on Agency implementation of its AMT 
Designation Program.
    Finally, section 506L of the FD&C Act also provides for the 
issuance of guidance. In the Federal Register of December 13, 2023 (88 
FR 86333), we issued the draft guidance document entitled ``Advanced 
Manufacturing Technologies Designation Program,'' to communicate the 
goals, scope, and framework of the new program. We invited public 
comment under both our good guidance practices regulation in 21 CFR 
10.115, and applicable PRA regulations in 5 CFR part 1320 and received 
a few comments. The comments included some requests for procedural 
clarification but focused mostly on requests for clarification of 
technical specifications and technologies that might qualify for AMT 
designation. Although we have updated the guidance document to address 
a number of public comments, we continue to implement the program and 
refine Agency processes.
    FDA estimates the burden of the information collection as follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
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                                                                                         Number of
                      Section 506L(c) FD&C Act                          Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents      respondents       responses       per response
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Submitting AMT designation requests; FDA Guidance for Industry,                  20                1               20               10              200
 section III.B.....................................................
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\1\ There are no capital or operating and maintenance costs associated with the information collection.

    Based on our experience with similar information collection 
activities that involve requests for FDA determinations, along with 
related preliminary and followup communications, we assume 10 hours is 
needed to complete the activities provided for in section 506L of the 
FD&C Act and discussed in the referenced guidance document. Although we 
have received fewer than 10 requests for AMT designation thus far, we 
are hopeful that 20 respondents will submit requests for AMT 
designation under the program.

    Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-29954 Filed 12-17-24; 8:45 am]
BILLING CODE 4164-01-P
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